Indolent B-cell Non-Hodgkin's LymphomaPhase 1NCT01933516
GP2013 in Japanese Patients With CD20 Positive Low Tumor Burden Indolent B-cell Non-Hodgkin's Lymphoma
A Phase 1 study testing GP2013 in people with Indolent B-cell Non-Hodgkin's Lymphoma, run by Sandoz at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate safety and pharmacokinetic of GP2013 in Japanese patients with CD20 positive low tumor burden indolent B-cell NHL under weekly dosing schedule. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Indolent B-cell Non-Hodgkin's Lymphoma
- What is being tested?
- GP2013
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteJapan
- Study dates
- May 2013to Aug 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with CD20 positive low tumor burden indolent B-cell non- Hodgkin's lymphoma.
- Patient with at least one measurable lesion.
- Patient with ECOG performance status 0 or 1.
Who cannot join
- Patient who has received radiotherapy within the last 28 days prior to administration, or are not recovered from previous radiotherapy.
- Patient who has received immunotherapy, chemotherapy, antibodies and experimental treatment within the last 28 days prior to administration, or are not recovered from previous therapy.
- Patient who has mAb therapy other than rituximab as prior line of therapy.
- Patient with evidence of any uncontrolled, acute or chronic active infection (viral, bacterial or fungal).
- Patient with any other malignancy within 5 years prior to date of screening, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or nonmelanomatous skin cancer.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Trial to Assess the Safety and Pharmacokinetics of GP2013 Monotherapy Administered Weekly in Japanese Patients With CD20 Positive Low Tumor Burden Indolent B-cell Non-Hodgkin's Lymphoma
The purpose of this study is to evaluate safety and pharmacokinetic of GP2013 in Japanese patients with CD20 positive low tumor burden indolent B-cell NHL under weekly dosing schedule.
- Conditions
- Indolent B-cell Non-Hodgkin's Lymphoma
- Being tested
- GP2013
- Keywords
- GP2013, Japanese, indolent B-cell non-Hodgkin's lymphoma, biosimilar, CD20, GP13-101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GP2013Drug
GP2013
| Study group | Role | What they receive |
|---|---|---|
| GP2013 | Experimental | Not described Receives: Drug: GP2013 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate safety of GP2013
Adverse events, laboratory abnormalities
Measured: 12 weeks
Area under the curve calculated from start of dose to the end of the dosing interval (tau) of GP2013
Measured: 12 weeks
Maximum observed concentration of GP2013
Measured: 12 weeks
Time to reach maximum concentration of GP2013
Measured: 12 weeks
Minimum (trough) observed concentration during each dosing interval of GP2013
Measured: 12 weeks
Terminal elimination rate constant calculated as the slope of the linear regression of the terminal phase of the logarithmic concentration-time profile of GP2013
Measured: 12 weeks
Elimination half-life associated with the terminal slope of GP2013
Measured: 12 weeks
Secondary outcomes (3)
To evaluate efficacy of GP2013
Antitumor activity
Measured: 12 weeks
To evaluate the incidence of immunogenicity (ADA formation) against GP2013
Immunogenicity (ADA formation)
Measured: 12 weeks
To evaluate peripheral CD19+ B-cell count
CD19 + B-cell count
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2013 (estimated)
- Study startMay 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indolent B-cell Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Sandoz K.K., Study director, Sandoz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01933516
- Sponsor's protocol ID
- GP13-101
- Status last verified
- Jul 2018
- First submitted
- 8 Aug 2013
- Last updated
- 26 Jul 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial to Assess the Safety and Pharmacokinetics of GP2013 Monotherapy Administered Weekly in Japanese Patients With CD20 Positive Low Tumor Burden Indolent B-cell Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT01933516
- Acronym / sponsor ID
- GP13-101
- Conditions
- Indolent B-cell Non-Hodgkin's Lymphoma
- Keywords
- GP2013, Japanese, indolent B-cell non-Hodgkin's lymphoma, biosimilar, CD20, GP13-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- Collaborators
- Novartis Pharmaceuticals
- Study start
- May 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 2 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate safety and pharmacokinetic of GP2013 in Japanese patients with CD20 positive low tumor burden indolent B-cell NHL under weekly dosing schedule.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GP2013 | Experimental | Drug: GP2013 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with CD20 positive low tumor burden indolent B-cell non- Hodgkin's lymphoma.
- Patient with at least one measurable lesion.
- Patient with ECOG performance status 0 or 1.
Key exclusion criteria (6 listed)
- Patient who has received radiotherapy within the last 28 days prior to administration, or are not recovered from previous radiotherapy.
- Patient who has received immunotherapy, chemotherapy, antibodies and experimental treatment within the last 28 days prior to administration, or are not recovered from previous therapy.
- Patient who has mAb therapy other than rituximab as prior line of therapy.
- Patient with evidence of any uncontrolled, acute or chronic active infection (viral, bacterial or fungal).
- Patient with any other malignancy within 5 years prior to date of screening, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or nonmelanomatous skin cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GP2013GP2013 | Drug | GP2013 |
Primary outcome
To evaluate safety of GP2013
Time frame: 12 weeks
Adverse events, laboratory abnormalities
Area under the curve calculated from start of dose to the end of the dosing interval (tau) of GP2013
Time frame: 12 weeks
Maximum observed concentration of GP2013
Time frame: 12 weeks
Time to reach maximum concentration of GP2013
Time frame: 12 weeks
Minimum (trough) observed concentration during each dosing interval of GP2013
Time frame: 12 weeks
Terminal elimination rate constant calculated as the slope of the linear regression of the terminal phase of the logarithmic concentration-time profile of GP2013
Time frame: 12 weeks
Elimination half-life associated with the terminal slope of GP2013
Time frame: 12 weeks
3 secondary outcomes
To evaluate efficacy of GP2013
Time frame: 12 weeks
To evaluate the incidence of immunogenicity (ADA formation) against GP2013
Time frame: 12 weeks
To evaluate peripheral CD19+ B-cell count
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandoz K.K. study director
Sandoz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GP2013 in people with Indolent B-cell Non-Hodgkin's Lymphoma, run by Sandoz at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate safety of GP2013 (time frame: 12 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2018.